BEIJING, Dec. 3 -- The top food and drug agency is
streamlining approval procedures for importing drugs to treat the estimated
85,000 patients in the country suffering from full-blown AIDS.
The move came after China released its HIV/AIDS
prevalence and prevention assessment report for this year on Thursday, which
stated that about 700,000 people in the country are living with AIDS and the HIV
virus which causes the disease.
Zhang Wei, director with the drug registration
department of the State Food and Drug Administration (SFDA), said his
administration has always attached great importance to importing AIDS drugs.
"The approval work (for imported AIDS drugs) has
never stopped," Zhang said.
He said a streamlined approval method has been
adopted for imports of drugs that show significant clinical effects in treating
diseases such as AIDS and cancer.
A regulation on drug approval was also amended in
July making procedures more transparent and efficient, which could see certain
procedures going faster in special cases.
It costs 120 working days to register an AIDS drug
compared with 150 for most others, Zhang said.
Approval for the import of TDF, a key drug in the
second line of anti-retroviral treatment also known as the cocktail therapy for
AIDS, is currently under way and is expected to be completed in time, he said.
The United States-based Gliead, the drug's developer,
filed the required application in August, said Zhang.
So far, only seven kinds of AIDS drugs mainly
prescribed for first-line anti-retroviral treatment are available in China, with
37,497 AIDS patients reportedly getting free treatment with government aid.
About 10 percent of patients on the first-line
treatment, however, develop resistance after taking the drugs for one year and
have to switch to the second-line drugs to survive, said Hao Yao, deputy
director with the disease control department of the Health Ministry.
To reduce the drug resistance also faced by AIDS
patients in other countries, Hao strongly urged Chinese patients to stick to
their treatment as many kinds of drugs in the second-line cocktail treatment
such as TDF are still unavailable here and have to be imported from foreign
countries.
"We are aware of the pressing issues and are
considering further measures and policies," Zhang said.
Last week, the SFDA approved the import of
Lopinavir/ritonavir, produced by the US-based Abbott Laboratories, which is also
a crucial part of the second-line cocktail treatment.
In another development, the Ministry of Health has
launched a pilot scheme on second-line therapy in Henan, Anhui and Hubei
provinces, said Hao.
"This will be further expanded to the whole country,"
he said.
(Source: China Daily)